We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
This position is an onsite role. We prefer a candidate that can sit at our Santa Monica, CA site Tuesday, Wednesday, and Thursday. Our additional posting option is Parsippany, NJ where you will sit Tuesday, Wednesday, and Thursday.
Responsibilities (include but are not limited to):
Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging, or ECG)) data mappings)
To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
Managing work assignments to ensure timely delivery of global library objects
Identify and resolve issues that may negatively impact the delivery of global library objects and escalate to leadership as needed.
SME on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
Support and participate in the Standards Core Committee (SCC)
Partner with functional area stewards
Organize standards topics to be reviewed and ensure decisions are made on time
Document meeting minutes and other discussions
Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation
Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved
Medidata Rave global library standard objects (e.g., eCRF forms, edit checks)
Build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases
Work with Data Managers and EDC Programmers to implement new or modified global library objects (e.g., ensure DM and EDCP clearly understand global library objects).
Build and maintain CRF Completion Guidelines for all standard forms
Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed
Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.
Participate in relevant study and project team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF
Contributing to developing and applying smart systems and optimal approaches to support data collection.
Independently identify and propose process improvements while maintaining a strategic focus. Share new industry standards and best practices with project and study teams and departments as required
Liaising with and reviewing work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.)
Developing strong and productive working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite with the ability to think strategically across a broad portfolio and effectively express their views to senior management
Participate and/or lead in strategic initiatives, special projects, and working groups contributing to business decisions and process changes
Participate and/or lead in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids
Participate and/or lead in identifying, reviewing, evaluating, and implementing new data standards-related technologies
Develop training materials and provide training on CDSM and GLIB-developed processes
Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required
Representing the Company in interactions with key external partners as part of any committee or industry group
Requirements:
PhD in life sciences or related discipline and 0+ years of experience OR
MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR
BS/BA in life science or related discipline and 6+ years of experience in Clinical Data Standards OR
High School degree and 10+ years of experience in Clinical Data Standards
Preferred Qualifications:
MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards
6+ years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices.
Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
At least 8 years of clinical database developer experience in Rave with expertise in global library development and development of standard data collection objects.
Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio , Oracle, TrialGrid, etc.) and well-versed in industry trends and emerging technologies supporting data collection.
Understanding database and dictionary structures (e.g., MedDRA, WHODrug).
Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background.
Strong working knowledge of the overall pharmaceutical development process.
Strong working knowledge of SDTM and creating data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
Experience in CRF design, query resolution, and general data validation.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.